Clinical Trials/NCT02700685

NCT02700685

Completed

Phase 3

Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.

Nina Hermans3 sites in 1 country88 target enrollmentSeptember 1, 2017

ConditionsADHD

InterventionsPycnogenol Placebo Methylphenidate

DrugsMethylphenidate

Overview

Phase: Phase 3
Intervention: Pycnogenol
Conditions: ADHD
Sponsor: Nina Hermans
Enrollment: 88
Locations: 3
Primary Endpoint: Summed ADHD score of the ADHD-Rating Scale as rated by teachers
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

November 20, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nina Hermans

Responsible Party

Sponsor Investigator

Principal Investigator

Nina Hermans

Prof. Dr.

Universiteit Antwerpen

Eligibility Criteria

Inclusion Criteria

•The patient is between 6-12 years old (both inclusive).
•The patient satisfies the DSM-IV criteria for ADHD or ADD.
•The patient has a responsible caregiver who is able to provide information about the patient's functional status.
•Written informed consent is obtained from the patient and the legally accepted representative.

Exclusion Criteria

•The patient does satisfy the DSM-IV for autism spectrum disorder.
•The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ \< 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does not have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt.
•The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does not have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome.
•The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills.
•The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days.
•The patient has any other contraindication for the use of methylphenidate.
•The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) \> 1 week during the 3 months before inclusion.

Arms & Interventions

Pycnogenol

Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks. Subjects \< 30 kg body weight: 20 mg Pycnogenol/day Subjects \>= 30 kg body weight: 40 mg Pycnogenol/day

Intervention: Pycnogenol

Placebo

Placebo treatment (identical capsules containing excipients only)

Intervention: Placebo

Methylphenidate

Standard pharmaceutical treatment for ADHD, slow release. Subjects \< 30 kg body weight: 20 mg methylphenidate once per day Subjects \>= 30 kg body weight: 30 mg methylphenidate once per day

Intervention: Methylphenidate

Outcomes

Primary Outcomes

Summed ADHD score of the ADHD-Rating Scale as rated by teachers

Time Frame: 10 weeks

Secondary Outcomes

Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention(5 & 10 weeks)
Social behavior problems subscale of the SEQ, as rated by parents and teachers(10 weeks)
Anxiety subscale of the SEQ, as rated by parents and teachers(10 weeks)
Urinary 8-OHdG level(10 weeks)
Plasma antibody levels(10 weeks)
Gene expression(10 weeks)
Serum neuropeptide Y(10 weeks)
Serum zinc(10 weeks)
Summed ADHD score of the ADHD-Rating Scale as rated by teachers(5 weeks)
Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers(10 weeks)
Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention(5 & 10 weeks)
Percentage of responders (ADHD-RS) as rated by parents and teachers(5 & 10 weeks)
Summed ADHD score of the ADHD-Rating Scale as rated by parents(5 weeks, 10 weeks)
Percentage of responders (SEQ) as rated by parents and teachers(5 & 10 weeks)
Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)(5 & 10 weeks)
Erythrocyte glutathione (GSH) level(10 weeks)
Plasma cytokine levels(10 weeks)
Intestinal microbial composition(10 weeks)
Intervention acceptability(10 weeks)
Long-term follow up(6 months)
Urinary catecholamines(10 weeks)
Plasma lipid-soluble vitamins(10 weeks)